Associate Director, Drug Product Technology

The Role:

Reporting to the Senior Director, Drug Product Technology, this position is responsible for the drug product process technical transfer of biologics (monoclonal antibodies). This role will be a key contributor within the CMC organization at Immunovant. The successful candidate will have a proven track record in leading the technical transfer of biologic clinical and/or commercial programs.

Key Responsibilities:

• Drive the technical transfer of drug product process of a key biological entity and partner with key Immunovant CMC personnel to ensure success.
• Perform process transfer, scale-up and lead facility fit activities such as facility gap assessment, raw material assessment, process risk assessment, develop tech transfer protocol and others.
• Partnering with internal/external teams to ensure process transfer.
• Apply scientific and engineering principles to support process scale-up fill/finish operations and provide technical direction to CMOs for tech transfer, process characterization, and process validation.
• Utilize product and process knowledge to author Drug Product Process Control Strategy and monitor/trend process performance to establish/improve process capability.
• Review and approve cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications) required to support cGMP production at manufacturing facilities.
• Develop and apply risk-based strategies for process validation throughout product lifecycle. This includes continuous process verification and control strategy establishment with associated enabling documents (i.e. validation or supporting technical studies).
• Manage and author SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices
• Create/Review relevant technical sections of regulatory dossier or other communications to health authority.

Requirements:

• Masters or PhD in engineering, chemistry, biological science or another relevant field
• Eight to ten years of relevant biopharmaceutical industry experience with experience in process development, technical transfer, process validation, environmental and microbial monitoring, change controls, and manufacturing of biologics (combination product (combination product with assembly process experience preferred).
• Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship
• Experience directly working in CMO environment would be preferred
• Proven leadership in process engineering, scale-up and process transfer.
• Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals
• Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
• Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
• Ability to think outside of the box and challenge the status quo
• Natural entrepreneurial spirit with unrelenting dedication to delivering results
• Desire to work in a fast-paced, innovative environment
• Natural collaborator who enjoys working on a cross-functional team

Work Environment:

• Dynamic, interactive, fast-paced, and entrepreneurial environment
• 20-30% travel to manufacturing sites, and other locations